NDC 73310-1522 Face And Body Spf 15

Octinoxate, Oxybenzone, Avobenzone

NDC Product Code 73310-1522

NDC 73310-1522-3

Package Description: 150 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Face And Body Spf 15 with NDC 73310-1522 is a a human over the counter drug product labeled by Agefarm Srl. The generic name of Face And Body Spf 15 is octinoxate, oxybenzone, avobenzone. The product's dosage form is cream and is administered via topical form.

Labeler Name: Agefarm Srl

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Face And Body Spf 15 Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • OXYBENZONE 1 mg/5mL
  • AVOBENZONE 1 mg/5mL
  • OCTINOXATE 1 mg/5mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Agefarm Srl
Labeler Code: 73310
FDA Application Number: part352 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 08-28-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Face And Body Spf 15 Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredients

OctinoxateOxybenzoneAvobenzone

Purpose

Sunscreen

Uses

Helps prevent sunburnUse as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warning

For external use only.Do not use on damaged or broken skin.When using this product keep out of eyes. Rinse with water to remove.Stop use and ask a doctor if rash occurs.Keep out of reach of children. If product swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply liberally, 15 minutes before sun exposureReapply: at least every 2 hoursUse a water-resistant sunscreen if swimming or sweatingSUN PROTECTION MEASURES. Spending time in the sun increases your risk of skin cancer and early skin aging.To decrease this risk,regulary use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:Limit time in the sun,especially from 10 a.m.- 2 p.m.Wear long-sleaved shirts, pants, hats, and sunglussesChildren under 6 months. Ask a doctor

Inactive Ingredients

Water, C12-15 alkyl benzoate, disopropyl sebacate, isononyl isononanoate, squalane, glyceril stearate, cocos nucifera oil, cetearyl alcohol, propylene glycol, peg-100 stearate, glycerin, dimethicone, vp/eicosene copolymer, calendula officinalis flower extract, ammonium acryloyldimethyltaurate, vp/copolymer, bixia orellana seed extract, hydrolyzed wheat protein, hydrolyzed soy protein, tocopherol, tocopheryl acetate, tripeptide-10 citrulline, caprylic/capric triglyceride, xanthan gum, pseudoalteromonas ferment extract, tripeptide-1, lecithin, carbomer, triethanolamine, benzyl alcohol, dimethiconol behenate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, diethylhexyl syringylidenemalonate, parfum, hexyl cinnamal, coumarin, limonene, linalool, citronellol, menthyl lactate, ethylhexylglycerin, polysorbate 60

Storage

Protect this container from heat and sun

Sunscreen Label

SCREEN 1510 SPF 15

* Please review the disclaimer below.